Cleared Traditional

JEDMED LARYNGEAL SCOPE

K950925 · Jedmed Instrument Co. · Ear, Nose, Throat

Aug 1995

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K950925 is an FDA 510(k) clearance for the JEDMED LARYNGEAL SCOPE, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on August 11, 1995, 163 days after receiving the submission on March 1, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K950925 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1995
Decision Date	August 11, 1995
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).